Medicines watchdog recalls drugs made in India
The UK’s medicines watchdog is recalling 16 prescription medicines made at an Indian factory which failed a routine inspection.
The Medicines and Healthcare products Regulatory Agency wants pharmacies to go back stock of the medicine made by Wockhardt at its Waluj site.
The recalled drugs, in this article, include some for diabetes, schizophrenia and thyroid conditions.
But the MHRA stresses there’s no evidence of a risk to patient safety.
It says people shouldn’t have to come back their medicines and that it’s important patients continue to take them as prescribed.
It says there are other versions of many of the recalled drugs made by more than a few pharmaceutical companies.
And it said where other versions of an identical medicines weren’t available, there have been substitutes which doctors could prescribe,
A statement from the MHRA said it was not recalling the medicines people had at home because, although they’d not been manufactured to Good Manufacturing Practice standards, there has been no evidence of a patient safety risk from medicines which have been sold within the UK.
However, it said it needed to act inside the public interest – and poor manufacturing standards couldn’t be allowed to continue.
An inspection on the Waluj factory in March found some risk of cross-contamination due to poor cleaning practices, and defects in building fabric and the ventilation systems on the site.
There was also evidence of forged documents with regards to staff training records that were re-written.
The MHRA says it’s working with Wockhardt and other international regulators to unravel the difficulty.
The full range of conditions treated by the 16 medications include infections, hypertension, diabetes, epilepsy, depression, schizophrenia, Parkinson’s disease, dementia in Alzheimer’s patients and thyroid conditions.
Gerald Heddell, the MHRA’s director of inspection, enforcement and standards, said: “This can be a precautionary recall.
“People may be reassured that there’s no evidence that medicines made by Wockhardt are defective so it will be significant people continue to take their medicines as prescribed.
“All batches of medications manufactured outside the ecu Union are tested on importation to the united kingdom before they reach patients.
“However, now we have taken this precautionary action since the medicines haven’t been manufactured to the correct regulatory standards.
“We’re working with the dep. of Health making sure that people have access to the medicines they want.
“Anyone who has questions should speak to their pharmacist or GP.”